KeratoconusNCT03229239
Corneal Stroma Implantation for the Treatment of Keratoconus
A study testing corneal stroma implantation in people with Keratoconus, run by Shandong Eye Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine whether corneal stroma implantation is effective in the treatment of keratoconus. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Keratoconus
- What is being tested?
- corneal stroma implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 11 Aug 2017to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Advanced and completed keratoconus patients
- Voluntarily signed informed consent
- No surgery and anesthesia contraindications
Who cannot join
- Acute edema of cornea
- Primary keratoconus patients
- The patients combined systemic diseases
- Reject study and follow visit
- Cannot tolerate surgery or anesthesia
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shandong Eye Hospital
Jinan, Shandong
Suxia Li, Doctor, 15854107085, ykyykjk@163.com
Weiyun Shi, Doctor, 13953218357, weiyunshi@163.com
About this study
Official title: Implant the Corneal Stroma to the Diseased Cornea in Order to Cure Keratoconus
The purpose of this study is to determine whether corneal stroma implantation is effective in the treatment of keratoconus.
Read the detailed description
Keratoconus is a corneal disease with the progressive thinning of the central corneal stroma. The main treatment methods are corneal transplantation, corneal collagen cross-linking, etc. The effect of corneal collagen cross-linking is limited, and the lack of donor cornea is really a very big problem. In this pilot project, investigators would like to study whether corneal stroma implantation can increase the biomechanics of the cornea, which can, to some extent, delay the progress of keratoconus. This will allowed us to determine if useful data can be obtained, and if so, the donor cornea can be greatly saved.
- Conditions
- Keratoconus
- Being tested
- corneal stroma implantation
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
corneal stroma implantationProcedure or surgery
During the operation,implant the corneal stroma to the diseased cornea of keratoconus.
| Study group | Role | What they receive |
|---|---|---|
| corneal stroma implantation | Experimental | implant the corneal stroma to the diseased cornea of keratoconus patients Receives: Procedure: corneal stroma implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The best corrected visual acuity of the operated eye
To check whether the best corrected visual acuity，which is scaled by the integrated refractometer,is improved after surgery.
Measured: 1 month after operation
The best corrected visual acuity of the operated eye
To check whether the best corrected visual acuity，which is scaled by the integrated refractometer,is improved after surgery.
Measured: 3 months after operation
The best corrected visual acuity of the operated eye
To check whether the best corrected visual acuity，which is scaled by the integrated refractometer,is improved after surgery.
Measured: 6 months after operation
The best corrected visual acuity of the operated eye
To check whether the best corrected visual acuity，which is scaled by the integrated refractometer,is improved after surgery.
Measured: 12 months after operation
Secondary outcomes (4)
The biomechanics of the operated eye
To check whether the biomechanics,which is scaled by the corvis ST is improved after surgery.
Measured: 1 month after operation
The biomechanics of the operated eye
To check whether the biomechanics,which is scaled by the corvis ST is improved after surgery.
Measured: 3 months after operation
The biomechanics of the operated eye
To check whether the biomechanics,which is scaled by the corvis ST is improved after surgery.
Measured: 6 months after operation
The biomechanics of the operated eye
To check whether the biomechanics,which is scaled by the corvis ST is improved after surgery.
Measured: 12 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start11 Aug 2017
- Primary completion11 Aug 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weiyun Shi, sponsor, Study chair, director of shandong eye hosiptal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03229239
- Sponsor's protocol ID
- 20170717
- Status last verified
- Aug 2017
- First submitted
- 16 Jul 2017
- Last updated
- 24 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Li N, Liu M, Tian G, Chen T, Lin Y, Qi X, Shi W, Gao H. Effects of femtosecond laser-assisted minimally invasive lamellar keratoplasty (FL-MILK) on mild-to-moderate and advanced keratoconus. Graefes Arch Clin Exp Ophthalmol. 2023 Oct;261(10):2873-2882. doi: 10.1007/s00417-023-06093-2. Epub 2023 May 12.
PubMed 37171602
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implant the Corneal Stroma to the Diseased Cornea in Order to Cure Keratoconus
- ClinicalTrials.gov ID
- NCT03229239
- Acronym / sponsor ID
- 20170717
- Conditions
- Keratoconus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shandong Eye HospitalUniversity, hospital or other
- Study start
- 11 Aug 2017 (actual)
- Primary completion
- 11 Aug 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 25 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether corneal stroma implantation is effective in the treatment of keratoconus.
Detailed description
Keratoconus is a corneal disease with the progressive thinning of the central corneal stroma. The main treatment methods are corneal transplantation, corneal collagen cross-linking, etc. The effect of corneal collagen cross-linking is limited, and the lack of donor cornea is really a very big problem. In this pilot project, investigators would like to study whether corneal stroma implantation can increase the biomechanics of the cornea, which can, to some extent, delay the progress of keratoconus. This will allowed us to determine if useful data can be obtained, and if so, the donor cornea can be greatly saved.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| corneal stroma implantation | Experimental | Procedure: corneal stroma implantationimplant the corneal stroma to the diseased cornea of keratoconus patients |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Advanced and completed keratoconus patients
- Voluntarily signed informed consent
- No surgery and anesthesia contraindications
Key exclusion criteria (5 listed)
- Acute edema of cornea
- Primary keratoconus patients
- The patients combined systemic diseases
- Reject study and follow visit
- Cannot tolerate surgery or anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| corneal stroma implantationDuring the operation,implant the corneal stroma to the diseased cornea of keratoconus. | Procedure or surgery | corneal stroma implantation |
Primary outcome
The best corrected visual acuity of the operated eye
Time frame: 1 month after operation
To check whether the best corrected visual acuity，which is scaled by the integrated refractometer,is improved after surgery.
The best corrected visual acuity of the operated eye
Time frame: 3 months after operation
To check whether the best corrected visual acuity，which is scaled by the integrated refractometer,is improved after surgery.
The best corrected visual acuity of the operated eye
Time frame: 6 months after operation
To check whether the best corrected visual acuity，which is scaled by the integrated refractometer,is improved after surgery.
The best corrected visual acuity of the operated eye
Time frame: 12 months after operation
To check whether the best corrected visual acuity，which is scaled by the integrated refractometer,is improved after surgery.
4 secondary outcomes
The biomechanics of the operated eye
Time frame: 1 month after operation
The biomechanics of the operated eye
Time frame: 3 months after operation
The biomechanics of the operated eye
Time frame: 6 months after operation
The biomechanics of the operated eye
Time frame: 12 months after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2017.
- Derived from this study: PubMed 37171602Li N, Liu M, Tian G, Chen T, Lin Y, Qi X, Shi W, Gao H. Effects of femtosecond laser-assisted minimally invasive lamellar keratoplasty (FL-MILK) on mild-to-moderate and advanced keratoconus. Graefes Arch Clin Exp Ophthalmol. 2023 Oct;261(10):2873-2882. doi: 10.1007/s00417-023-06093-2. Epub 2023 May 12.
- Individual participant dataSharing planned: Undecided
Related trials for Keratoconus
RecruitingObservational study
UNITY DX Cornea Study
Tomography
Not yet recruiting
Performance Evaluation of the OCUTOP Hand-held Corneal Topographer
Corneal Topography, Dry Eye Syndromes
Recruiting
Proof-of-Concept for a Novel Optical Aperture Contact Lens in Presbyopia and Keratoconus
Keratoconus, Presbyopia
RecruitingObservational study
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
Keratoconus, Ectasia
Enrolling by invitationObservational study
Corneal Biomechanical Analysis Using Brillouin Microscopy
Keratoconus, Keratoconus, Unstable
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weiyun Shi, sponsor study chair
director of shandong eye hosiptal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing corneal stroma implantation in people with Keratoconus, run by Shandong Eye Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mingna Liu, researcher (8613589089612, lmn_2422@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The best corrected visual acuity of the operated eye (time frame: 1 month after operation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03229239, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2017.